Kornimate/medical-research-clean huggingface dataset:
falls prevention: gait-synchronized vibration system

Conditions: Sensory Deficits

Summary: the purpose of this study is to develop an abnormal gait detection algorithm and a vibratory stimulation system on a lower limb to improve gait stability and prevent falls. the investigators want to detect, assess and communicate fall risk indicators obtained via the shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar surface in reducing fall risk.the system consists of a gait measurement module, an abnormal gait detection module, and a vibratory stimulation module.

forty (40) individuals with decreased confidence in ambulatory scores (\<80%) as per the activities specific balance confidence questionnaire, will undergo functional assessments for visual (snellen chart, humphrey visual field testing, gaze stabilization test, depth perception evaluation), vestibular (dizziness handicap inventory, head thrust test) and proprioceptive (balance master, berg balance scale, joint position sense) impairments, to evaluate factors which might contribute to increased falls risk. participants will be asked to walk return for a second visit and to walk with a shoe sensor and gait synchronized vibratory stimulus under conditions of (1) baseline performance on the six minute walk test (2) performance on the six minute walk test and dynamic gait index without vibratory stimulus (3) performance on the six minute walk test and dynamic gait index with vibratory stimulus.

Eligibility criteria:
inclusion criteria: 1. individuals aged 65 or greater. 2. low balance confidence (scores \<80%) on the abc balance confidence scale 3. berg balance scale (bbs) scores between 21 (moderate fall risk) and 56 (low fall risk). exclusion criteria: 1. no internal implantable device (i.e. pacemaker, intrathecal baclofen pump) 2. significant painful arthritis (scores 15 or greater) as per the short arthritis assessment scale. 3. significant cognitive deficits (scores \<2) as per ascertain dementia 8 (ad8) questionnaire. 4. significant visual field deficits as per the humphrey visual field analysis or significant uncorrected visual acuity deficits as per the snellen eye chart. 5. current treatment with anticoagulation medication 6. parkinson's disease or known peripheral neuropathy 7. limitations to exercise related to cardiac, neurological or pulmonary diseases 8. orthostatic hypotension 9. severe osteoporosis defined by fracture history, bmd by dexa (t score more than 2.5 standard deviations below controls in the last 2 years), or height loss of more than 3 cm 10. current treatment with corticosteroids or aromatase inhibitor 11. current treatment with seizure medication

Keywords: balance gait falls sensory deficits vibration visual acuity dizziness postural control proprioceptive function stereoacuity depth perception vestibular dysfunction
sleep, the never-ending quest of college students

Conditions: Sleep; Sleep Disturbance; Sleep Hygiene

Summary: the purpose of this study is to evaluate whether undergraduate students completing a course focused entirely on sleep at a major urban university evidence positive changes in their sleep patterns compared to students completing a similar-level course (without any discussion of sleep) in the same department (psychology) at the same university (uh). potential changes in sleep patterns across the semester will be examined as well as whether putative changes in sleep can be linked with academic and mental health outcomes.

aim 1) to evaluate whether a semester long course focused entirely on sleep produces improvements in college students' sleep patterns across the semester based on one-week sleep diaries. h1: compared to students enrolled in other courses who are not expected to show significant changes in sleep patterns, students enrolled in the sleep course will demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings. in line with mayer's theoretical model, these sleep-based changes will evidence non-linear (i.e., quadractic) patterns across four time points during the semester. aim 2) to evaluate changes in sleep hygiene behaviors across the semester among students enrolled in a sleep course compared to students enrolled in other courses. h2: compared to students enrolled in other courses who are not expected to show significant changes in sleep hygiene behaviors, students enrolled in the sleep course will report a decreased frequency of naps, use of electronics within one hour of bed, and an increase in sleep regularity (e.g., reduction in the discrepancy between weekend and weekday wake times) across the four time points during the semester. aim 3) to evaluate how sleep patterns relate to daytime mood and energy levels across the semester among students enrolled in a sleep course and other courses. h3: greater total sleep time, shorter sleep onset latency, fewer nighttime awakenings, a less discrepancy between weekend and weekday wake times will predict higher energy levels and mood among both groups across the semester. aim 4) to evaluate how sleep patterns across the semester predict final course grades among students enrolled in a sleep course. h4: students enrolled in the sleep course who demonstrate increases in total sleep time, decreases in sleep onset latency, and decreases in nighttime awakenings across the semester will achieve higher final course grades than students who demonstrate minimal to no improvements in sleep.

Eligibility criteria:
inclusion criteria: * all undergraduate students at uh age 18 and older who are enrolled in the following upper-level courses and who provide consent to participate will be eligible to participate as control participants exclusion criteria: * previous enrollment in psyc 4397: the behavior of sleep course or a similar course.
evaluating the effects of a study medication on exercise function in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: people who are overweight or who have type 2 diabetes mellitus (t2dm) have higher levels of certain fats in their blood. the blood vessels and heart of most of these individuals do not work normally and people with t2dm also have an impaired ability to perform exercise. the purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with t2dm and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. this will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have t2dm.


Eligibility criteria:
inclusion criteria: * sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week) * subjects must have type 2 diabetes * subjects must be otherwise healthy * ages of 30-60 years * bmi of 25-39 and stable weight for 3 months prior to the start of the study * diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose). * total glycosylated hemoglobin levels (hba1c) ≤9% (fair control) on current therapy. exclusion criteria: * any comorbid condition which could limit exercise performance including chronic obstructive pulmonary disease (copd) or asthma * concurrent enrollment in an interventional study. * any tobacco use either current or within the last year * clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded. * autonomic dysfunction (\>20 mm fall in upright bp without a change in heart rate) will be excluded. * evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (ekg) (\> 1 mm st segment depression) on screening exercise test. * angina or any other cardiovascular, pulmonary or musculoskeletal symptoms * presence of systolic blood pressure \>190 at rest or \>250 with exercise or diastolic pressure \>95 at rest or \>105 with exercise * proteinuria (urine protein \>200 mg/dl) or a creatinine \> 2 mg/dl, suggestive of severe renal disease * proliferative retinopathy * insulin, incretin, or glitazone treatment * niacin treatment * history of peptic ulcers * a history of hereditary angioedema * c1 esterase deficiency * women who are pregnant or breastfeeding * use of fibrate drugs

Keywords: diabetes exercise cardiovascular heart insulin sensitivity
efficacy and safety of bez235 compared to everolimus in patients with advanced pancreatic neuroendocrine tumors

Conditions: Pancreatic Neuroendocrine Tumors (pNET)

Summary: this was a multicenter, open label, randomized phase ii study to evaluate the efficacy and safety of bez235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pnet).

patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pnet) were randomized to either bez235 or everolimus. the study was planned to include 140 patients, with 70 patients in the bez235 treatment group and 70 patients in the everolimus treatment group. an interim analysis was conducted on 62 randomized patients. the study was terminated as the bez235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.

Eligibility criteria:
inclusion criteria: * advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor * progressive disease within the last 12 months * measurable disease per recist version 1.0 determined by multiphase mri or triphasic ct exclusion criteria: * prior treatment with mtor or pi3k inhibitors * patients with more than 2 prior systemic treatment regimens * previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks other protocol-defined inclusion/exclusion criteria may apply

Keywords: pancreatic neuroendocrine tumors pnet bez235 everolimus
utilising hull lung health study data to investigate the performance of tidalsense diagnostic algorithms to identify copd and pre-copd among participants in the frontier programme.

Conditions: COPD; Emphysema or COPD; Emphysema

Summary: aim: to investigate the potential for n-tidal to improve copd diagnosis and enable detection of pre-copd\*. objectives: 1. to assess the performance of tidalsense copd diagnostic algorithms for copd diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among frontier programme participants. 2. to assess the performance of tidalsense copd diagnostic algorithms for identification of pre-copd. 3. evaluate tidalsense copd diagnostic algorithms ability to identify those at risk of developing copd within 1-year. aim: explore the blood biomarker profile among frontier programme participants to explore a potential role in early copd identification. objectives: 1. investigate the blood biomarker profile (obtained from the hull lung health study data) of people with i) confirmed copd, ii) pre-copd, and iii) no evidence of copd. 2. explore a potential role for blood biomarkers in copd diagnostics. * pre-copd is defined, as per the gold report 2023, as individuals who have respiratory symptoms and/or other detectable structural and/or functional abnormalities in the absence of airflow obstruction on forced spirometry. for the purpose of this study, respiratory symptoms will be classified as a cat score \> 10 during frontier clinic attendance and presence of emphysema on low-dose ct considered evidence of structural lung abnormalities


Eligibility criteria:
all hull lung health study participants that attend a one-stop diagnostic clinic appointment as part of the frontier programme (nhs lung health check) will be eligible for inclusion in this study. prospective consent provided for use of data for research purposes and for future contact as part of the hull lung health study inclusion criteria: * participants in the hull lung health check programme (ever smokers aged 55-75 and registered with a hull gp) with one or more of the following symptoms during their lung health check: * breathlessness * cough * bronchitis * recurrent infections * and/or evidence of emphysema on low dose ct exclusion criteria: -existing copd diagnosis noted at the time of their lung health check or new copd diagnosis since lung health check attendance and prescribed appropriate copd therapy.

Keywords: copd hull lung health tidalsense n-tidal
astigmatism in keratoconus patients

Conditions: Keratoconus

Summary: keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. it manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.

keratoconus is the most common form of corneal ectasia, with an incidence of 50-230 per 100,000 persons.pentacam used diagnose \& detect the progression in patients with keratoconus and also provide a detailed information about corneal tomography and topography. in the last few years, it has been shown that in healthy individuals the posterior corneal surface has not only a different amount of astigmatism but also a different alignment of the steep meridian. the aim of this research is to compare the amount and axis alignment of anterior and posterior corneal astigmatism in keratoconus with a healthy controlled group .

Eligibility criteria:
inclusion criteria: * patients diagnosed with keratoconus using the following criteria: specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, vogt striae, fleischer rings, inferior or central steepening on topography with abnormal localized steepening . exclusion criteria: * unwillingness to participate in the study . * corneal scarring. * any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration . * previous ocular surgery.
acute treatment of migraine using the cefaly device

Conditions: Migraine

Summary: the purpose of this study is to investigate the efficacy of e-tns with the cefaly® device as an acute treatment for a migraine attack. this open clinical trial will study the acute treatment of migraine using the cefaly® device, prior to development of a sham-controlled trial.


Eligibility criteria:
inclusion criteria: * patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ichd-iii beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction) * the patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. the location of the headache should be frontal, retro- or peri- orbital, on one or either side. exclusion criteria: * pregnant women * patients having received treatment with onabotulinum toxin (e.g., botox, dysport, xeomin) to the head in the prior 4 months * patients having received supraorbital nerve blocks in the prior 4 months * diagnosis of other primary or secondary headache disorders, except of medication overuse headache * patients with only temporal or occipital headaches * patients taking opioid medications * patients having taken abortive migraine medication in the prior 3 hours * allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded while the neurostimulation has already started). * implanted metal or electrical devices in the head * cardiac pacemaker or implanted or wearable defibrillator
partner ii trial: placement of aortic transcatheter valves ii - xt intermediate and high risk

Conditions: Symptomatic Severe Aortic Stenosis

Summary: the purpose of this trial is to determine the safety and effectiveness of the edwards sapien xt transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

the piia cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. patients randomized to the treatment arm will receive an edwards sapien xt thv with either transfemoral, transapical or transaortic delivery access. patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery. to assure that patients with an sts score ≥ 4% have been selected.

Eligibility criteria:
inclusion criteria 1. patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmhg or jet velocity greater than 4.0 m/s and an initial aortic valve area (ava) of ≤0.8 cm2 or indexed eoa \< 0.5 cm2/m2 qualifying echo must be within 60 days of the date of the procedure. 2. patient is symptomatic from his/her aortic valve stenosis, as demonstrated by nyha functional class ii or greater. 3. the heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient. 4. the study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board (irb) of the respective clinical site. 5. the study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up. 6. study patient agrees to undergo surgical aortic valve replacement (savr) - if randomized to control treatment. exclusion criteria 1. evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[defined as: q wave mi, or non-q wave mi with total ck elevation of ck-mb ≥ twice normal in the presence of mb elevation and/or troponin level elevation (who definition)\]. 2. aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. 3. mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+). 4. preexisting mechanical or bioprosthetic valve in any position (except nr3). 5. any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). implantation of a permanent pacemaker or icd (s3 cohort only) is not excluded. 6. heart team assessment of inoperability (including examining cardiac surgeon).

Keywords: sapien xt transfemoral transapical transaortic novaflex tavi aortic stenosis thv aortic valve transcatheter heart valve tavr
ischemic preconditioning in osteoarthritis and back pain

Conditions: Low Back Pain; Knee Osteoarthritis

Summary: we are examining the use of restricted blood flow, through full occlusion, on a single thigh for 50 minutes (5 minutes on, 5 minutes off), completed every other day for 2 weeks to improve function in individuals with knee osteoarthritis and low back pain.


Eligibility criteria:
inclusion criteria: * reported knee pain using acr criteria * reported back pain using odi criteria \> 12 * ability to walk for at least 3 minutes without the use of aids * ability to provide written informed consent exclusion criteria: * younger than 50 years old * history of knee or hip replacements * history of steroid injection within the previous 6 months * presence of neuromuscular joint condition that affects lower extremity function * history of blood clots in the leg or any condition in which compression of the thigh is contraindicated * history of heart failure or thrombosis * allergic to ultrasound gel * history of spine surgery * non-english speaker * currently pregnant or intends to become pregnant during the study

Keywords: ischemic preconditioning restricted blood flow knee pain back pain
the impact of omega-3 fatty acid supplements on fibromyalgia symptoms

Conditions: Fibromyalgia

Summary: the purpose of this study is to find out if omega-3 fatty acid supplements are more effective than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * women aged 18-65. * a diagnosis of fm according to the american college of rheumatology classification criteria(wolfe et al., 1990) * negative urine pregnancy test at enrolment and willingness not to become pregnant for the duration of the study. * pain levels of at least 4 on 10-cm vas at the time of recruitment. * ability to communicate in english or in french. * willing to sign an informed consent. * if the patient is taking medication or natural health product (excluding omega-3 containing products) to treat fibromyalgia, she must be on a stable regimen for a minimum of two weeks before recruitment and be willing to keep this stable medication or natural health product regimen throughout the study period. * if the patient is using other therapies to treat fibromyalgia such as tens, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc, she must be doing so for a minimum of two weeks before recruitment and be willing to continue those therapies throughout the study period. exclusion criteria: * use of anticoagulants (coumadin® or plavix®), having a bleeding disorder or being scheduled for a surgical procedure. this is because omega-3 fatty acids can prolong bleeding time, although doses we propose to use are safe (see risks section) * allergy to fish, olive oil, medium chain triglycerides, lemon, green tea, vitamin e or tylenol * past (within the last year) or present specific dietary supplementation with omega-3 fish oil or other natural health products containing omega-3 fatty acids (e.g. flax seed oil, krill oil, etc) or regularly eating more than two fatty fish meals/week (salmon, mackerel, sardine, flounder, herring, or any other fish considered to have a high level of omega-3 fatty acids). * patient enrolled in another research study involving any treatment. * patient engaged in active litigation * regular use of recreational drugs * alcohol consumption \> 10 units/week * morbidly obese patients * pregnancy or breastfeeding * uncontrolled major medical conditions. neurological problems. current psychiatric condition. chronic pain condition other than fm.

Keywords: fibromyalgia omega-3 chronic pain fatigue mood docosahexaenoic acid (dha) eicosapentaenoic acid (epa)